A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration
Purpose
The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)
Conditions
- Neovascular Age-related Macular Degeneration
- nAMD
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Men or women ≥ 50 years old, capable of giving signed informed consent - Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE) - Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE - The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE - Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol: - Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye - Scar, fibrosis, or atrophy involving the central subfield in the study eye - Scar or fibrosis involving > 50% of the total lesion in the study eye - Presence of retinal pigment epithelium tears or rips involving the macula in the study eye - History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study - Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study - Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye - History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye - Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization - Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening - Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins - History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation - Other protocol-specified exclusion criteria
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABP 938 8 mg |
Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study. |
|
|
Active Comparator Aflibercept (US) 8 mg |
Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study. |
|
Recruiting Locations
Fullerton, California 92835-3432
Long Beach, California 90607
Modesto, California 95356
Pasadena, California 91107
Sacramento, California 95825
Santa Barbara, California 93103
Colorado Springs, Colorado 80909-1183
Colorado Springs, Colorado 80909
Lakewood, Colorado 80228
Waterford, Connecticut 06385
Miami, Florida 33143
Naples, Florida 34103-4457
Pensacola, Florida 32503
Elmhurst, Illinois 60126
Carmel, Indiana 46032
Baltimore, Maryland 21209
Hagerstown, Maryland 21740-5846
Towson, Maryland 21204
Boston, Massachusetts 02114
Edina, Minnesota 55435
Madison, Mississippi 39110
St Louis, Missouri 63128
Bloomfield, New Jersey 07003
Albuquerque, New Mexico 87109
Liverpool, New York 13088
Oceanside, New York 11572
Raleigh, North Carolina 27607-7514
Wake Forest, North Carolina 27587
Dublin, Ohio 43016
Kingston, Pennsylvania 18704-4801
Beaufort, South Carolina 29902
Charleston, South Carolina 29414-5896
Columbia, South Carolina 29169
Ladson, South Carolina 29456
Mt. Pleasant, South Carolina 29464
West Columbia, South Carolina 29169
Nashville, Tennessee 37203
Arlington, Texas 76012
Austin, Texas 78705
Bellaire, Texas 77401
Dallas, Texas 75231
Fort Worth, Texas 76104
Houston, Texas 77401
San Antonio, Texas 78240
Schertz, Texas 78154
Willow Park, Texas 76087
Salt Lake City, Utah 84107
Falls Church, Virginia 22042-2349
Bellevue, Washington 98004-3779
Silverdale, Washington 98383
Spokane, Washington 99204-2509
More Details
- Status
- Recruiting
- Sponsor
- Amgen